PO 2 LYTRODE

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K843538 ↗

FDA Product Code

DRY

Device Class

Class II

Regulation

21 CFR Part 870.4330

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Polystan Two Stage Catheters

  Class II

  FDA 510(k) K874853 Active Cleared 5 Feb 1988

• Polystan Heater-Cooler Unit

  Class II

  FDA 510(k) K893940 Active Cleared 18 Jan 1990

• Polystan Wire Reinforced Catheters and Cannulae

  Class II

  FDA 510(k) K872182 Active Cleared 30 Oct 1987

• Polystan Wire Reinforced Two Stage Catheters

  Class II

  FDA 510(k) K874852 Active Cleared 5 Feb 1988

• Polystan Heart-Lung Machine System

  Class II

  FDA 510(k) K894657 Active Cleared 28 Mar 1990

• Safe-1 Venous Reservoir

  Class II

  FDA 510(k) K893705 Active Cleared 22 Dec 1989

See all devices from Polystan C/O Vitalcor, Inc. →

• What is the PO 2 LYTRODE used for?

  The PO 2 LYTRODE is a blood-gas monitor designed for online use during cardiopulmonary bypass procedures. It is used to monitor blood-gas parameters in real time during surgical procedures involving the heart and lungs, providing critical data for clinical decision-making.

• What regulatory classification does the PO 2 LYTRODE have?

  The PO 2 LYTRODE is classified as a class II medical device under regulation 870.4330. It falls within the cardiovascular medical specialty and is regulated under product code DRY, indicating its specific classification for blood-gas monitoring equipment.

• When was the PO 2 LYTRODE cleared?

  The PO 2 LYTRODE was submitted for FDA 510(k) clearance under K843538 and received a substantially equivalent decision on October 18, 1984. The application was received on September 7, 1984, and the decision code was SESE, indicating substantial equivalence to existing devices.

• Who manufactures the PO 2 LYTRODE?

  The PO 2 LYTRODE is manufactured by Polystan C/O Vitalcor, Inc., located in Ballerup, Denmark. The company's address is Walgerholm 8, and the contact person is HENNING S LARSEN, with the country code listed as US for regulatory purposes.